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March 2018

The EMA may be moving to Amsterdam but in her speech on Friday 2 March Theresa May confirmed that the UK still wants to be part of the EMA. Her proposal is that the UK continues as an "associate member" of the EMA. The detail is understandably light but the proposal would include abiding by the rules of the EMA and making appropriate financial contributions. There are also, the Prime Minister explains, advantages to the UK and to the EU. Products would only need to undergo one series of approvals and the UK would remain part of the larger EU market and so continue to enjoy investment and access to new innovative medicines and the EU would have continued access to the MHRA, which has carried out a large share of the product assessments to date, and to the UK's world-leading universities. But what of the UK's red lines and, in particular, the CJEU? The Prime Minister explains that Parliament would remain sovereign because it could decide not to accept the EMA's rules, although she acknowledged that this would have consequences for continued membership.

Associate membership of the EMA for non-EU states does not exist at the moment. Norway, Iceland and Liechtenstein are part of the EMA in that they recognise decisions from the agency but do not participate in the assessment of those medicines or contribute to the guidance adopted by the EMA. The Prime Minister's proposal is not something that has any precedent and so will require creativity on both sides of the negotiating table and it is unclear whether it will be possible to achieve it. For now, however, these are welcome words to the industry which has been pressing for a solution which maintains cooperation between regulators and avoids the need for duplicate applications to the EU and the UK.

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